Monitoring of Corticosteroids Induced Immunosuppression Using Monocyte Human Leukocyte Antigen-DR (mHLA-DR).

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04360772
Collaborator
(none)
95
44

Study Details

Study Description

Brief Summary

Corticotherapy is widely used in auto-immune diseases. If induced immunosuppression by corticosteroids is well admitted, it's currently not possible to determine individual risk of infection. Thus, the development of new biomarkers able to reflect immunological status under immunosuppressive treatments is needed. It would help identifying patients who would benefit from adapted treatment protocols or infectious prophylaxis. In this field, the mHLA-DR (monocyte Human Leukocyte Antigen-DR) has shown encouraging results. However, it has never been used in patients treated by immunosuppressive therapies. The investigators aim to describe changes induced by corticosteroids in mHLA-DR expression in vivo. To achieve this goal, the investigators will measure mHLA-DR before treatment, after 1 months, 3 months and 6 months of treatment. Finally, the investigators will look for correlation between the level of expression of mHLA-DR and the cumulated dose of corticosteroids administered.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: mHLA-DR

Study Design

Study Type:
Observational
Anticipated Enrollment :
95 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Monitoring of Corticosteroids Induced Immunosuppression Using mHLA-DR
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2026
Anticipated Study Completion Date :
Sep 1, 2026

Outcome Measures

Primary Outcome Measures

  1. Kinetics of mHLA-DR expression determined by flow cytometry before treatment and during the 6 first months of degressive corticosteroids doses [Month 1, 3 and 6]

    mHLA-DR expression level will be compared between : Before treatment and at 1 month of treatment Before treatment and at 3 months of treatment Before treatment and at 6 months of treatment 1 month and 3 months of treatment 1 month and 6 months of treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Patient aged of 18 years old or more, male or female.

  • Patient diagnosed with any pathology indicating a treatment by corticotherapy at 1mg/kg/day.

  • Patient who didn't express any opposition to be enrolled in the study after reading the dedicated information letter.

  • Patient affiliated to social heath care regimen

Exclusion Criteria:
  • Treatment by corticosteroids in the previous 6 months.

  • Immunsuppressive treatment (except for corticosteroids) in the previous 2 years.

  • Patient under judicial protection, guardianship or curators

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

  • Principal Investigator: ARNAUD HOT, MD, Service de Médecine Interne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT04360772
Other Study ID Numbers:
  • 69HCL19_1029
First Posted:
Apr 24, 2020
Last Update Posted:
Jan 19, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospices Civils de Lyon

Study Results

No Results Posted as of Jan 19, 2022